The present study aims to evaluate efficacy and feasibility of an online group intervention for parents of children with cancer that focuses on the specific issues that play a role in parents coping with a child with cancer. Hypothesis: Participants…
ID
Source
Brief title
Condition
- Other condition
Health condition
Pediatric Oncology
Research involving
Sponsors and support
Intervention
- Psychosocial intervention
Outcome measures
Primary outcome
Primary study parameters reflect psychosocial wellbeing, measured with validated standardized questionnaires that are completed online by the parents. Differences between intervention condition and waitlist-control condition in change over time on wellbeing are tested. Questionnaires used for the primary outcomes: - Patient Reported Outcomes Measurement Information System (PROMIS) item banks - anxiety and depression (Computer adaptive testing) - Hospital anxiety and depression scale (HADS) - anxiety and depression - Distress Thermometer for Parents (DT-P) - parental overall distress, thermometer score only - Situation-Specific Emotional Reaction Questionnaire (SSERQ) - Situation-Specific Emotional Reactions - Pediatric Quality Of Life Inventory Family Impact Module (PedsQL FIM) - Family relationships and Worry - Insomnia Severity Index (ISI) – Insomnia
Secondary outcome
Secondary study parameters reflect coping (online questionnaires) and feasibility (both questionnaires with course leaders and participants, and the recording of logistical and recruitment issues).
Background summary
RATIONALE Childhood cancer in the family is stressful for all family members and has long-term consequences for the patients as well as their parents and siblings, including the risk of developing psychosocial problems. The standards of psychosocial care for parents of children with cancer state that access to appropriate interventions for parents and caregivers should be facilitated to optimize parent, child, and family wellbeing. Evidence-based interventions targeted at parents of children with cancer are needed. OBJECTIVE The present study aims to evaluate efficacy and feasibility of a cognitive behavioral-based online group intervention that focuses on the specific issues that play a role in parents coping with a child with cancer. The intervention, led by psychologists, aims to improve psychosocial wellbeing and to prevent psychosocial problems by improving coping skills. STUDY DESIGN A Randomized Controlled Trial (RCT) with two conditions (Intervention and Waitlist-control) is proposed to assess the efficacy of the online intervention. Feasibility of the intervention will be assessed cross-sectionally. STUDY POPULATION Parents are eligible if their child is diagnosed with any cancer at the age of 0-18 years, is within 5 years from diagnosis, and is still living with their parents at the time of recruitment. INTERVENTION The intervention under study is Op Koers Online for parents in pediatric oncology. The main goal of the intervention is to improve psychosocial wellbeing and to prevent psychosocial problems by teaching active use of coping skills. To teach coping skills, cognitive behavioral techniques and acceptance and commitment techniques are used. The intervention consists of protocolled chat sessions with three to six parents under supervision of trained course leaders (psychologist with an assistant).
Study objective
The present study aims to evaluate efficacy and feasibility of an online group intervention for parents of children with cancer that focuses on the specific issues that play a role in parents coping with a child with cancer. Hypothesis: Participants in the intervention group have better coping skills and better psychosocial functioning than participants in the control group, at T1 and T2.
Study design
T0 (before intervention), T1 (directly after intervention 6-8 weeks after T0), T2 (six months after T0). The intervention condition will have an additional measurement at T3 (one year after T0).
Intervention
The intervention under study is Op Koers Online for parents in pediatric oncology. The main goal of the intervention is to improve psychosocial wellbeing and to prevent psychosocial problems by teaching active use of coping skills. To teach coping skills, cognitive behavioral techniques and acceptance and commitment techniques are used. The intervention consists of protocolled chat sessions with three to six parents under supervision of trained course leaders (psychologist with an assistant).
Mala Joosten
0650006729
m.joosten@prinsesmaximacentrum.nl
Mala Joosten
0650006729
m.joosten@prinsesmaximacentrum.nl
Age
Inclusion criteria
Parents are eligible for the study - if their child was diagnosed before with childhood cancer at the age of 0-18 years; - if their child is within 5 years from diagnosis for childhood cancer (during or after successful treatment) - if their child still lives with his/her parent(s) - if they have access to a laptop/computer with internet connection - when they have provided written informed consent
Exclusion criteria
Parents who meet any of the following criteria are excluded from participation: - parents who are not able to follow a group chat course - parents who are not able to fill out Dutch questionnaires
Design
Recruitment
IPD sharing statement
Huispostnr D01.343
Postbus 85500
3508 GA Utrecht
088 755 6376
metc@umcutrecht.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8565 |
| CCMO | NL73763.041.20 |
| OMON | NL-OMON49373 |